• SeaStar Medical's SCD device receives FDA Breakthrough Device Designation for treating chronic systemic inflammation in end-stage renal disease (ESRD) patients undergoing hemodialysis.
• The SCD targets dysregulated immune responses, aiming to improve survival rates and quality of life for over 480,000 chronic hemodialysis patients in the U.S.
• The designation expedites SCD's development and review process, granting priority review, early patient access, and potential for differentiated market positioning.
• SeaStar Medical aims to demonstrate that SCD therapy can improve survival and clinical outcomes for patients undergoing chronic dialysis by modulating proinflammatory neutrophils and monocytes.